Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

THIORIDAZINE CONCENTRATE - ORAL

(thigh-oh-RID-uh-zeen)

COMMON BRAND NAME(S): Mellaril

WARNING: Serious heart problems (QTc interval prolongation) have occurred in patients taking thioridazine. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. This medicine should be used only when treatment with other drugs have failed.

Uses

This medication is used to treat a mental/emotional condition (schizophrenia) that is untreatable with other drugs. It may be used for other conditions as determined by your doctor.

How To Use

Take with food or milk if stomach upset occurs, unless directed otherwise by your doctor. Your dosage is based on your condition and response to the medication. This medication must be used exactly as prescribed. Do not increase the dose or stop taking this drug without first consulting your doctor. Measure carefully and dilute with 4 ounces or more of water, milk, juice or carbonated beverage. It can be mixed into applesauce or pudding. Do not dilute with coffee, tea, colas or apple juice because the medication may lose effectiveness. Take immediately after diluting. Do not dilute the drug and save for later use. It must be diluted before each dose. In the treatment of mental or emotional conditions it may take up to two weeks for the full benefit of the medication to take effect.

Side Effects

Constipation, drowsiness, vision changes or dry mouth may occur. If any of these effects persist or worsen, notify your doctor. Unlikely to occur, but report promptly: restlessness, muscle stiffness, weakness, difficulty speaking, loss of balance, mask- like facial expression, trembling or shaking, lip smacking or other uncontrollable movements, skin rash/discoloration, difficulty urinating. Very unlikely to occur, but report immediately: dizziness, sore throat, unusual bleeding or bruising, stomach pain, yellowing of eyes or skin, dark urine, hot dry skin, vomiting. Though highly unlikely to occur, notify your doctor immediately if you experience any of the following very serious side effects: fainting, irregular heartbeat, confusion, fever, seizures, severe muscle stiffness, increased sweating, prolonged/painful erection. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history, especially of: blood pressure problems (high or low), heart disease, liver disease, irregular heartbeat, Reye's syndrome, alcohol or drug alcohol or drug dependency, nervous system problems, blood blood disorders, any allergies (especially drug allergies). Use caution performing tasks that require alertness such as driving or operating machinery Use of alcohol can cause extreme drowsiness. Avoid alcohol use. This medication may increase sensitivity to sunlight. Avoid prolonged sun exposure and wear a sunscreen and protective clothing when you are exposed to the sun. This medication can reduce sweating making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather. Elderly patients are more sensitive to the effects of this drug. Use cautiously. Children should be monitored closely while using this drug. This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Certain drugs closely related to this one (phenothiazines) have been detected in breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Inform your doctor about all the medications you may use (both prescription and nonprescription), especially of: anti-anxiety drugs, anti-depressants (including SSRI-type such as fluoxetine, paroxetine, and fluvoxamine), propranolol, pindolol, guanethidine, guanadrel, metrizamide, cabergoline, lithium, narcotic pain medication (e.g., codeine), medication for sleep, muscle relaxants, drowsiness-causing antihistamines (e.g., diphenhydramine), any other drugs that can make you drowsy. Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, quinidine, sotalol, procainamide, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Many cough-and-cold products contain ingredients that may add a drowsiness effect. Before using cough-and-cold medications, ask your doctor or pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, muscle spasms, tremors, twitching, deep sleep or loss of consciousness, and seizures.

Notes

Do not share this medication with others. Certain tests (such as EKG and electrolytes) may be done as part of drug monitoring before and during therapy.

Missed Dose

If you miss a dose and take 1 dose daily, take the missed dose as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual schedule. If you take more than 1 dose daily, take the missed dose as soon as possible if it is within an hour or so of the missed dose. If not remembered within an hour, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the original container at a room temperature not higher than 86 degrees F (30 degrees C). Keep away from sunlight and moisture. Do not store in the bathroom. Keep out of reach of children.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).